ISO 13485 quality-process support
Connect versioned procedures, readings, test-instrument context, evidence, sign-off and equipment history — to support the post-market processes your quality system defines.
Medeq can support controlled service processes and traceable post-market records. It does not establish ISO 13485 conformity, regulatory compliance, certification, or audit success.
Your organisation remains responsible for its quality system, controlled procedures, competent people, risk decisions, record retention, review, and evidence of effective implementation.
Medeq supports reusable, versioned checklist templates with an active version and configurable assignment by equipment and service context.
When Medeq instantiates a checklist for a job, the record retains the procedure instance used. Assignment coverage and procedure content still require quality ownership, approval, maintenance and validation.
Checklist entries can record observations, checks, notes, tables, collections and supported measurement units, with optional reference bounds and result vocabulary.
The software structure does not decide whether the procedure, limit, method or result is suitable for the organisation’s intended use.
Medeq can record test instruments, calibration expiry, certificate and report. Checkout requires an instrument to be available with a future calibration expiry.
The job retains instrument assignment, return and swap activity. This supports job-level traceability but does not replace calibration procedures, competence, physical controls, or quality review.
Parts, consumables, labour, photos, supporting files, technician and site contact can remain linked to the job.
The service PDF can bring the configured work and instrument context into one record, followed by technician and site-contact sign-off through the selected method. Layout, storage, retention, signing method, email flow and legal treatment depend on the deployed configuration and organisational controls.
Once the configured signing flow completes, Medeq can return the completed document to equipment and ticket history in iTop.
That relationship helps reviewers trace the request, device, procedure, readings, tools, service items, evidence, people and signed record — without treating the application as the quality system itself.
Use the connected record to review installation, inspection, preventive maintenance, calibration, repair and decommissioning, when your team has configured those processes and records.
Complaint, escalation, recall, correction and broader post-market processes need their own organisational procedures and system configuration. The field workflow covers only the processes in the agreed scope.
Bring a service procedure and completed-record requirement. We compare it against the controls available in Medeq and your deployed iTop environment.
